Translating Research to Clinical Practice

Trzeciak, Stephen; Dellinger, R. Phillip; Abate, Nicole L.; Cowan, Robert M.; Stauss, Mary; Kilgannon, J. Hope; Zanotti, Sergio; Parrillo, Joseph E.

doi:10.1378/chest.129.2.225

Cited by 276 publications

(39 citation statements)

References 13 publications

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“…9,11,54,60,61 However, almost all these studies relied solely on observational data, 9,11,60,61 and so the finding that EGDT was associated with improved survival, and higher QALYs, could reflect confounding by indication. Neither ProCESS nor ARISE undertook a fully integrated cost-effectiveness analysis.…”

Section: Economic Evaluationmentioning

confidence: 99%

Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock

Mouncey

Osborn

Power

et al. 2015

Health Technol Assess

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BackgroundEarly goal-directed therapy (EGDT) is recommended in international guidance for the resuscitation of patients presenting with early septic shock. However, adoption has been limited and uncertainty remains over its clinical effectiveness and cost-effectiveness.ObjectivesThe primary objective was to estimate the effect of EGDT compared with usual resuscitation on mortality at 90 days following randomisation and on incremental cost-effectiveness at 1 year. The secondary objectives were to compare EGDT with usual resuscitation for requirement for, and duration of, critical care unit organ support; length of stay in the emergency department (ED), critical care unit and acute hospital; health-related quality of life, resource use and costs at 90 days and at 1 year; all-cause mortality at 28 days, at acute hospital discharge and at 1 year; and estimated lifetime incremental cost-effectiveness.DesignA pragmatic, open, multicentre, parallel-group randomised controlled trial with an integrated economic evaluation.SettingFifty-six NHS hospitals in England.ParticipantsA total of 1260 patients who presented at EDs with septic shock.InterventionsEGDT (n = 630) or usual resuscitation (n = 630). Patients were randomly allocated 1 : 1.Main outcome measuresAll-cause mortality at 90 days after randomisation and incremental net benefit (at £20,000 per quality-adjusted life-year) at 1 year.ResultsFollowing withdrawals, data on 1243 (EGDT,n = 623; usual resuscitation,n = 620) patients were included in the analysis. By 90 days, 184 (29.5%) in the EGDT and 181 (29.2%) patients in the usual-resuscitation group had died [p = 0.90; absolute risk reduction −0.3%, 95% confidence interval (CI) −5.4 to 4.7; relative risk 1.01, 95% CI 0.85 to 1.20]. Treatment intensity was greater for the EGDT group, indicated by the increased use of intravenous fluids, vasoactive drugs and red blood cell transfusions. Increased treatment intensity was reflected by significantly higher Sequential Organ Failure Assessment scores and more advanced cardiovascular support days in critical care for the EGDT group. At 1 year, the incremental net benefit for EGDT versus usual resuscitation was negative at −£725 (95% CI −£3000 to £1550). The probability that EGDT was more cost-effective than usual resuscitation was below 30%. There were no significant differences in any other secondary outcomes, including health-related quality of life, or adverse events.LimitationsRecruitment was lower at weekends and out of hours. The intervention could not be blinded.ConclusionsThere was no significant difference in all-cause mortality at 90 days for EGDT compared with usual resuscitation among adults identified with early septic shock presenting to EDs in England. On average, costs were higher in the EGDT group than in the usual-resuscitation group while quality-adjusted life-years were similar in both groups; the probability that it is cost-effective is < 30%.Future workThe ProMISe (Protocolised Management In Sepsis) trial completes the planned trio of evaluations of EGDT across the USA, Australasia and England; all have indicated that EGDT is not superior to usual resuscitation. Recognising that each of the three individual, large trials has limited power for evaluating potentially important subgroups, the harmonised approach adopted provides the opportunity to conduct an individual patient data meta-analysis, enhancing both knowledge and generalisability.Trial registrationCurrent Controlled Trials ISRCTN36307479.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 97. See the NIHR Journals Library website for further project information.

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Section: Economic Evaluationmentioning

confidence: 99%

Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock

Mouncey

Osborn

Power

et al. 2015

Health Technol Assess

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“…This company had paid or supported the research of the primary developer and two co-developers of SEP-1 30373839. AdvaMed is a medical technology trade association that promoted Edwards’s and other manufacturers’ devices 40.…”

Section: Bundle Of Performance Measures For Sepsismentioning

confidence: 99%

Endorsing performance measures is a matter of trust

Jaswal

Natanson

Eichacker

2018

BMJ

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“…This collaboration has been found to reliably facilitate the achievement of EGDT end points in real-world sepsis resuscitation. 24 The implementation of a sepsis resuscitation protocol has been demonstrated to significantly reduce the time until therapeutic interventions occur in daily practice. 22 It is this time to intervention that has garnered a great deal of attention in recent years.…”

Section: Discussionmentioning

confidence: 99%

Improving Outcomes in Patients With Sepsis

et al. 2014

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Sepsis mortality may be improved by early recognition and appropriate treatment based on evidence-based guidelines. An intervention was developed that focused on earlier identification of sepsis, early antimicrobial administration, and an educational program that was disseminated throughout all hospital units and services. There were 1331 patients with sepsis during the intervention period and 1401 patients with sepsis during the control period. After controlling for expected mortality, patients in the intervention period had 30% lower odds of dying (odds ratio = 0.70, 95% confidence interval [CI] = 0.57 to 0.84). They also had 1.07 fewer days on average in the intensive care unit (95% CI = −1.98 to −0.16), 2.15 fewer hospital days (95% CI = −3.45 to −0.86), and incurred on average $1949 less in hospital costs, although the effect on costs was not statistically significant. Continued incremental improvement and sustainment is anticipated through organizational oversight, continued education, and initiation of an automated electronic sepsis alert function.

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Translating Research to Clinical Practice

Cited by 276 publications

References 13 publications

Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock

Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock

Endorsing performance measures is a matter of trust

Improving Outcomes in Patients With Sepsis

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